The following data is part of a premarket notification filed by Hk Surgical, Inc. with the FDA for Klein Surgical Infiltration Pump, Model Kip-ii.
| Device ID | K031432 |
| 510k Number | K031432 |
| Device Name: | KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II |
| Classification | Pump, Infusion |
| Applicant | HK SURGICAL, INC. 2620A TEMPLE HEIGHTS DR. Oceanside, CA 92675 |
| Contact | Sally M Bowdon |
| Correspondent | Sally M Bowdon HK SURGICAL, INC. 2620A TEMPLE HEIGHTS DR. Oceanside, CA 92675 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-06 |
| Decision Date | 2003-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08169890200135 | K031432 | 000 |
| 08169890200128 | K031432 | 000 |